CN105362425A - Kidney-reinforcing tonic tablet and preparation method thereof - Google Patents
Kidney-reinforcing tonic tablet and preparation method thereof Download PDFInfo
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- CN105362425A CN105362425A CN201510913371.3A CN201510913371A CN105362425A CN 105362425 A CN105362425 A CN 105362425A CN 201510913371 A CN201510913371 A CN 201510913371A CN 105362425 A CN105362425 A CN 105362425A
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K36/00—Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
- A61K36/18—Magnoliophyta (angiosperms)
- A61K36/185—Magnoliopsida (dicotyledons)
- A61K36/27—Asclepiadaceae (Milkweed family), e.g. hoya
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K36/00—Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
- A61K36/18—Magnoliophyta (angiosperms)
- A61K36/185—Magnoliopsida (dicotyledons)
- A61K36/29—Berberidaceae (Barberry family), e.g. barberry, cohosh or mayapple
- A61K36/296—Epimedium
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K36/00—Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
- A61K36/18—Magnoliophyta (angiosperms)
- A61K36/185—Magnoliopsida (dicotyledons)
- A61K36/63—Oleaceae (Olive family), e.g. jasmine, lilac or ash tree
- A61K36/638—Ligustrum, e.g. Chinese privet
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K36/00—Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
- A61K36/18—Magnoliophyta (angiosperms)
- A61K36/185—Magnoliopsida (dicotyledons)
- A61K36/73—Rosaceae (Rose family), e.g. strawberry, chokeberry, blackberry, pear or firethorn
- A61K36/738—Rosa (rose)
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K36/00—Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
- A61K36/18—Magnoliophyta (angiosperms)
- A61K36/185—Magnoliopsida (dicotyledons)
- A61K36/75—Rutaceae (Rue family)
- A61K36/752—Citrus, e.g. lime, orange or lemon
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/20—Pills, tablets, discs, rods
- A61K9/2004—Excipients; Inactive ingredients
- A61K9/2009—Inorganic compounds
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/20—Pills, tablets, discs, rods
- A61K9/2004—Excipients; Inactive ingredients
- A61K9/2013—Organic compounds, e.g. phospholipids, fats
- A61K9/2018—Sugars, or sugar alcohols, e.g. lactose, mannitol; Derivatives thereof, e.g. polysorbates
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/20—Pills, tablets, discs, rods
- A61K9/2004—Excipients; Inactive ingredients
- A61K9/2022—Organic macromolecular compounds
- A61K9/205—Polysaccharides, e.g. alginate, gums; Cyclodextrin
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/20—Pills, tablets, discs, rods
- A61K9/2004—Excipients; Inactive ingredients
- A61K9/2022—Organic macromolecular compounds
- A61K9/205—Polysaccharides, e.g. alginate, gums; Cyclodextrin
- A61K9/2054—Cellulose; Cellulose derivatives, e.g. hydroxypropyl methylcellulose
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K2236/00—Isolation or extraction methods of medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicine
- A61K2236/30—Extraction of the material
- A61K2236/37—Extraction at elevated pressure or temperature, e.g. pressurized solvent extraction [PSE], supercritical carbon dioxide extraction or subcritical water extraction
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K2236/00—Isolation or extraction methods of medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicine
- A61K2236/50—Methods involving additional extraction steps
- A61K2236/51—Concentration or drying of the extract, e.g. Lyophilisation, freeze-drying or spray-drying
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Abstract
The invention discloses a kidney-reinforcing tonic tablet and a preparation method thereof. The preparation method is characterized by including subjecting 150g of immature bitter orange, 75g of cortex periplocae radicis, 150g of herba epimedii, 75g of fructus rosae laevigatae and 75g of glossy privet fruit to supercritical carbon dioxide extraction and drying under reduced pressure, pulverizing into nanometer dry extract by a high-energy nanoimpact mill and adding functional minor ingredients so as to obtain a kidney-reinforcing tonic tablet. The kidney-reinforcing tonic tablet and the preparation method thereof have the advantages that disintegration time is shortened remarkably, and treatment effect of the kidney-reinforcing tonic tablet is superior to that of commercially-available kidney-reinforcing tonic tablets.
Description
Technical field
The present invention relates to the field of Chinese medicines, be specifically related to a kind of BUSHEN QIANGSHEN PIAN and preparation method thereof.
Background technology
BUSHEN QIANGSHEN PIAN kidney-tonifying health-care.Soft for soreness of waist foot, dizziness and tinnitus, dim eyesight cardiopalmus, impotence and seminal emission.Commercially available BUSHEN QIANGSHEN PIAN is due to prescription and technological reason, and curative effect is not satisfactory, and preparation adopts traditional handicraft preparation, there is the deficiencies such as prolonged disintegration, curative effect are low.
Summary of the invention
The present invention, for overcoming above-mentioned deficiency, provides BUSHEN QIANGSHEN PIAN that a kind of disintegration rate is fast, curative effect is high and preparation method thereof.
Invention embodiment is as follows:
Get Fructus Aurantii Immaturus 150g, Cortex Periplocae 75g, Herba Epimedii 150g, Fructus Rosae Laevigatae 75g, Fructus Ligustri Lucidi 75g, be ground into 60 order coarse powder, employing carbon dioxide supercritical extraction method is extracted, extracting pressure 24 ~ 39Mpa, extraction temperature 16 ~ 35 DEG C, separator pressure 11 ~ 19Mpa, separator temperature 45 ~ 53 DEG C, disengaging time 2.1 ~ 3.7 hours, carbon dioxide flow 23 ~ 38L per hour, obtains extracting solution; Get extracting solution 61 ~ 77 DEG C of drying under reduced pressure, get dry extract; Get dry cream and add citric acid 80 ~ 120g, adopt the impact grinding of high energy nanometer to be ground into the mixing dried cream powder of particle diameter 200 ~ 300nm; Get mixing dried cream powder, microcrystalline Cellulose 35 ~ 45g, hyprolose 35 ~ 45g, cross-linking sodium carboxymethyl cellulose 35 ~ 45g, aluminium-magnesium silicate 15 ~ 25g, sodium chloride 5 ~ 15g, mannitol 4 ~ 6g, maltodextrin 4 ~ 6g, mix homogeneously, with 50 ~ 70% ethanol wet granulations, 60 DEG C ~ 80 DEG C dryings, additional sodium alginate 7 ~ 9g, boric acid 1 ~ 3g, granulate, tabletting, obtained BUSHEN QIANGSHEN PIAN 1000.
The raw material standards that above-mentioned embodiment is mentioned is as follows:
Fructus Aurantii Immaturus: China's coastal port one ministerial standard.This product is the dry young fruit of rutaceae Citrus aurantium Linn. CitrusaurantiumL. and variety or Fructus Citri sinensis CitrussinensisOsbeck.Collect the fruit from falling the 5-6 month, removing impurity, be two halves from middle part crosscut, dry or cold drying, smaller directly dries or cold drying.
Cortex Periplocae: China's coastal port one ministerial standard.This product is the dry root bark of asclepiadaceae plant P. sepium Bunge PeriplocasepiumBge..Spring, Qiu Erji dig, and strip root bark, dry.
Herba Epimedii: China's coastal port one ministerial standard.This product is Berberidaceae plant Herba Epimedii EpimediumbrevicornumMaxim., Epimedium sagittatum Epimediumsagittatum(Sieb.etZucc.) dry aerial parts of Maxim., E. Pubescens EpimediumpubescensMaxim., Wushan excessive sheep work EpimediumwushanenseT.S.Ying or Herba Epimedii EpimediumkoreanumNabai.Tap when summer, autumn, stem and leaf was luxuriant, the thick stalk of removing and impurity, dry or dry in the shade.
Fructus Rosae Laevigatae: China's coastal port one ministerial standard.This product is the dry mature fruit of rosaceous plant Fructus Rosae Laevigatae RosalaevigataMichx..Gather when the 10-11 month, fruit maturation reddened, dry. except deburring.
Fructus Ligustri Lucidi: China's coastal port one ministerial standard.This product is the dry mature fruit of Oleaceae plants Fructus Ligustri Lucidi LigustrumlucidumAit..Gather during fruit maturation in winter, removing branch and leaf, after slightly steaming or putting in boiling water and slightly scald, dry; Or convection drying.
Citric acid: Chinese Pharmacopoeia version two ministerial standard in 2010.
Microcrystalline Cellulose: Chinese Pharmacopoeia version two ministerial standard in 2010.
Hyprolose: Chinese Pharmacopoeia version two ministerial standard in 2010.
Cross-linking sodium carboxymethyl cellulose: Chinese Pharmacopoeia version two ministerial standard in 2010.
Aluminium-magnesium silicate: Chinese Pharmacopoeia version two ministerial standard in 2010.
Sodium chloride: Chinese Pharmacopoeia version two ministerial standard in 2010.
Mannitol: Chinese Pharmacopoeia version two ministerial standard in 2010.
Maltodextrin: Chinese Pharmacopoeia version two ministerial standard in 2010.
Sodium alginate: Chinese Pharmacopoeia version two ministerial standard in 2010.
Boric acid: Chinese Pharmacopoeia version two ministerial standard in 2010.
Raw material used by above BUSHEN QIANGSHEN PIAN all can be bought from pharmaceuticals and obtain, and all can be used to implement the present invention program as long as meet national standard.
In foregoing invention scheme, term used is pharmacy proprietary term, as " decompression " etc. all defers to Chinese Pharmacopoeia regulation and pharmaceutical practice of being correlated with.
Unit g in the present invention also can be other weight portion, does not affect the enforcement of the present invention program.
Equipment Market described in the present invention program all has sale, is not limited to typical production producer, as long as technical specification can reach requirement, all can be used to realize the present invention.
Four detailed description of the invention
Specific embodiments of the invention 1
Get Fructus Aurantii Immaturus 150g, Cortex Periplocae 75g, Herba Epimedii 150g, Fructus Rosae Laevigatae 75g, Fructus Ligustri Lucidi 75g, be ground into 60 order coarse powder, employing carbon dioxide supercritical extraction method is extracted, extracting pressure 24Mpa, extraction temperature 16 DEG C, separator pressure 11Mpa, separator temperature 45 DEG C, disengaging time 2.1 hours, carbon dioxide flow 23L per hour, obtains extracting solution; Get extracting solution 61 DEG C of drying under reduced pressure, get dry extract; Get dry cream and add citric acid 80g, adopt the impact grinding of high energy nanometer to be ground into the mixing dried cream powder of particle diameter 200 ~ 300nm; Get mixing dried cream powder, microcrystalline Cellulose 35g, hyprolose 35g, cross-linking sodium carboxymethyl cellulose 35g, aluminium-magnesium silicate 15g, sodium chloride 5g, mannitol 4g, maltodextrin 4g, mix homogeneously, with 50% ethanol wet granulation, 60 DEG C of dryings, additional sodium alginate 7g, boric acid 1g, granulate, tabletting, obtained BUSHEN QIANGSHEN PIAN 1000.
Specific embodiments of the invention 2
Get Fructus Aurantii Immaturus 150g, Cortex Periplocae 75g, Herba Epimedii 150g, Fructus Rosae Laevigatae 75g, Fructus Ligustri Lucidi 75g, be ground into 60 order coarse powder, employing carbon dioxide supercritical extraction method is extracted, extracting pressure 39Mpa, extraction temperature 35 DEG C, separator pressure 19Mpa, separator temperature 53 DEG C, disengaging time 3.7 hours, carbon dioxide flow 38L per hour, obtains extracting solution; Get extracting solution 77 DEG C of drying under reduced pressure, get dry extract; Get dry cream and add citric acid 120g, adopt the impact grinding of high energy nanometer to be ground into the mixing dried cream powder of particle diameter 200 ~ 300nm; Get mixing dried cream powder, microcrystalline Cellulose 45g, hyprolose 45g, cross-linking sodium carboxymethyl cellulose 45g, aluminium-magnesium silicate 25g, sodium chloride 15g, mannitol 6g, maltodextrin 6g, mix homogeneously, with 70% ethanol wet granulation, 80 DEG C of dryings, additional sodium alginate 9g, boric acid 3g, granulate, tabletting, obtained BUSHEN QIANGSHEN PIAN 1000.
Specific embodiments of the invention 3
Get Fructus Aurantii Immaturus 150g, Cortex Periplocae 75g, Herba Epimedii 150g, Fructus Rosae Laevigatae 75g, Fructus Ligustri Lucidi 75g, be ground into 60 order coarse powder, employing carbon dioxide supercritical extraction method is extracted, extracting pressure 32Mpa, extraction temperature 26 DEG C, separator pressure 15Mpa, separator temperature 49 DEG C, disengaging time 2.9 hours, carbon dioxide flow 31L per hour, obtains extracting solution; Get extracting solution 69 DEG C of drying under reduced pressure, get dry extract; Get dry cream and add citric acid 100g, adopt the impact grinding of high energy nanometer to be ground into the mixing dried cream powder of particle diameter 200 ~ 300nm; Get mixing dried cream powder, microcrystalline Cellulose 40g, hyprolose 40g, cross-linking sodium carboxymethyl cellulose 40g, aluminium-magnesium silicate 20g, sodium chloride 10g, mannitol 5g, maltodextrin 5g, mix homogeneously, with 60% ethanol wet granulation, 70 DEG C of dryings, additional sodium alginate 8g, boric acid 2g, granulate, tabletting, obtained BUSHEN QIANGSHEN PIAN 1000.
Above embodiment illustrates, adopts the extreme condition of embodiment of the present invention and optimal conditions all can make BUSHEN QIANGSHEN PIAN.
Actual effect of the present invention is investigated below with the BUSHEN QIANGSHEN PIAN that embodiment 3 is obtained:
(1) embodiment 3 BUSHEN QIANGSHEN PIAN and contrast disintegration of commercially available BUSHEN QIANGSHEN PIAN
1 disintegration time mensuration method
Measure by Chinese Pharmacopoeia version annex Ⅻ A in 2010.
Contrast 2 disintegrations
Table 1 embodiment 3 BUSHEN QIANGSHEN PIAN and commercially available BUSHEN QIANGSHEN PIAN contrast table disintegration
The above results shows, BUSHEN QIANGSHEN PIAN prepared by the present invention has the remarkable advantages such as disintegration rate is fast, bioavailability is high relative to commercially available BUSHEN QIANGSHEN PIAN.
(2) embodiment 3 BUSHEN QIANGSHEN PIAN and commercially available BUSHEN QIANGSHEN PIAN treatment the soreness of waist foot soft, dizziness and tinnitus, dim eyesight cardiopalmus, impotence and seminal emission clinical observation on the therapeutic effect
1 case scenario
Statistics outpatient service and inpatient, observe soreness of waist foot soft, dizziness and tinnitus, dim eyesight cardiopalmus altogether, impotence and seminal emission case 147 example, 43 years old mean age.Patient is divided into two groups, test group takes embodiment 3 BUSHEN QIANGSHEN PIAN, and matched group takes commercially available BUSHEN QIANGSHEN PIAN.
2 efficacy assessment standards
According to new Chinese medicine treatment guideline of clinical investigations tcm syndrome curative effect determinate standard:
Clinical recovery: tcm clinical practice symptom, sign disappear or substantially disappear, syndrome integral reduces >=95%.
Effective: tcm clinical practice symptom, sign are obviously improved, syndrome integral reduces >=70%.
Effective: tcm clinical practice symptom, sign all take a favorable turn, syndrome integral reduces >=30%.
Invalid: tcm clinical practice symptom, sign are all not improved or increase the weight of, syndrome integral reduces < 30%.
Computing formula: [before (before treatment the rear integration of integration-treatment) ÷ treatment integration] × 100%.
3 clinical observation result
Table 2 embodiment 3 BUSHEN QIANGSHEN PIAN and commercially available BUSHEN QIANGSHEN PIAN clinical efficacy contrast table
Above-mentioned clinical observation on the therapeutic effect result shows, BUSHEN QIANGSHEN PIAN prepared by the present invention is soft at treatment soreness of waist foot, dizziness and tinnitus, and dim eyesight cardiopalmus is during impotence and seminal emission, evident in efficacy higher than commercially available BUSHEN QIANGSHEN PIAN, p < 0.05.
Claims (3)
1. a treatment soreness of waist foot is soft, dizziness and tinnitus, dim eyesight cardiopalmus, the Chinese medicine of impotence and seminal emission, is characterized in that getting Fructus Aurantii Immaturus 150g, Cortex Periplocae 75g, Herba Epimedii 150g, Fructus Rosae Laevigatae 75g, Fructus Ligustri Lucidi 75g, be ground into 60 order coarse powder, adopt carbon dioxide supercritical extraction method to extract, extracting pressure 24 ~ 39Mpa, extraction temperature 16 ~ 35 DEG C, separator pressure 11 ~ 19Mpa, separator temperature 45 ~ 53 DEG C, disengaging time 2.1 ~ 3.7 hours, carbon dioxide flow 23 ~ 38L per hour, obtains extracting solution; Get extracting solution 61 ~ 77 DEG C of drying under reduced pressure, get dry extract; Get dry cream and add citric acid 80 ~ 120g, adopt the impact grinding of high energy nanometer to be ground into the mixing dried cream powder of particle diameter 200 ~ 300nm; Get mixing dried cream powder, microcrystalline Cellulose 35 ~ 45g, hyprolose 35 ~ 45g, cross-linking sodium carboxymethyl cellulose 35 ~ 45g, aluminium-magnesium silicate 15 ~ 25g, sodium chloride 5 ~ 15g, mannitol 4 ~ 6g, maltodextrin 4 ~ 6g, mix homogeneously, with 50 ~ 70% ethanol wet granulations, 60 DEG C ~ 80 DEG C dryings, additional sodium alginate 7 ~ 9g, boric acid 1 ~ 3g, granulate, tabletting, obtained BUSHEN QIANGSHEN PIAN.
2. the preparation method of Chinese medicine according to claim 1, is characterized in that getting Fructus Aurantii Immaturus 150g, Cortex Periplocae 75g, Herba Epimedii 150g, Fructus Rosae Laevigatae 75g, Fructus Ligustri Lucidi 75g, be ground into 60 order coarse powder, adopt carbon dioxide supercritical extraction method to extract, extracting pressure 24 ~ 39Mpa, extraction temperature 16 ~ 35 DEG C, separator pressure 11 ~ 19Mpa, separator temperature 45 ~ 53 DEG C, disengaging time 2.1 ~ 3.7 hours, carbon dioxide flow 23 ~ 38L per hour, obtains extracting solution; Get extracting solution 61 ~ 77 DEG C of drying under reduced pressure, get dry extract; Get dry cream and add citric acid 80 ~ 120g, adopt the impact grinding of high energy nanometer to be ground into the mixing dried cream powder of particle diameter 200 ~ 300nm; Get mixing dried cream powder, microcrystalline Cellulose 35 ~ 45g, hyprolose 35 ~ 45g, cross-linking sodium carboxymethyl cellulose 35 ~ 45g, aluminium-magnesium silicate 15 ~ 25g, sodium chloride 5 ~ 15g, mannitol 4 ~ 6g, maltodextrin 4 ~ 6g, mix homogeneously, with 50 ~ 70% ethanol wet granulations, 60 DEG C ~ 80 DEG C dryings, additional sodium alginate 7 ~ 9g, boric acid 1 ~ 3g, granulate, tabletting, obtained BUSHEN QIANGSHEN PIAN.
3. the preparation method of Chinese medicine according to claim 1, is characterized in that getting Fructus Aurantii Immaturus 150g, Cortex Periplocae 75g, Herba Epimedii 150g, Fructus Rosae Laevigatae 75g, Fructus Ligustri Lucidi 75g, be ground into 60 order coarse powder, adopt carbon dioxide supercritical extraction method to extract, extracting pressure 32Mpa, extraction temperature 26 DEG C, separator pressure 15Mpa, separator temperature 49 DEG C, disengaging time 2.9 hours, carbon dioxide flow 31L per hour, obtains extracting solution; Get extracting solution 69 DEG C of drying under reduced pressure, get dry extract; Get dry cream and add citric acid 100g, adopt the impact grinding of high energy nanometer to be ground into the mixing dried cream powder of particle diameter 200 ~ 300nm; Get mixing dried cream powder, microcrystalline Cellulose 40g, hyprolose 40g, cross-linking sodium carboxymethyl cellulose 40g, aluminium-magnesium silicate 20g, sodium chloride 10g, mannitol 5g, maltodextrin 5g, mix homogeneously, with 60% ethanol wet granulation, 70 DEG C of dryings, additional sodium alginate 8g, boric acid 2g, granulate, tabletting, obtained BUSHEN QIANGSHEN PIAN.
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Application publication date: 20160302 |